N/A
N=240
GamePlan4Care: Online Support for Family Caregivers
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT04540198 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change From Baseline Caregiving Burden at 6 Months — -3.00; -2.75 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GamePlan4Care (Behavioral); Resources4Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor Research Institute
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Caregiving Burden at 6 Months |
-3.00; -2.75 | — |
| PRIMARY Change From Baseline Depression at 6 Months |
-1.57; -0.57 | — |
| PRIMARY Change From Baseline Social Support at 6 Months |
0.13; 0.01; 0.42; 0.46 | — |
| SECONDARY Change From Baseline Caregiver Stress at 6 Months |
-1.41; -1.22 | — |
| SECONDARY Change From Baseline Reported Positive Aspects of Caregiving at 6 Months |
1.95; 1.35 | — |
| SECONDARY Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months |
-2.62; -1.53 | — |
Summary
As the population of older adults grows, almost doubling in size from 2012 to 2040, so too will the need for family caregiving. Caregiving can lead to negative psychosocial outcomes such as depression, anxiety, and burden; social isolation and family conflict: financial strain due to costs of care; and some caregivers also experience negative health consequences. This project will test the value of GamePlan4Care (GP4C) an evidence-based, internet-enabled system capable of providing immediate, tailored education and skills training to caregivers who can access live support from a DCS via phone or web-based video.
Eligibility Criteria
Inclusion Criteria
- Must be age 18 years or older
- Providing at least 8 hours of weekly care and/or supervision (on average) for a friend or family member with a self-reported diagnosis of Alzheimer's disease or a related dementia. Family will be subjectively determined by the caregiver to enable a broader definition of a" "family" member often found in minority communities (e.g., a person not related by blood but who serves in the role of an "aunt" or "grandchild").
- The family member, named as the care recipient (CR) in this proposal, must be diagnosed with AD/ADRD (self-report from the caregiver accepted) and is experiencing signs of dementia as verified by the family caregiver on the AD8 informant interview. A score of 2 or greater is the inclusion criteria.
- Must demonstrate access to a home computer with internet access to research staff and report using the computer to access the internet at least three times per week, on average.
- English-speaking caregivers
- Must reside within the recruitment area (Target counties within Texas: Bastrop, Bell, Blanco, Burnet, Caldwell, Coryell, Fayette, Hamilton, Hays, Lampasas, Lee, Llano, Milam, Mills, San Saba, Travis, Williamson)
Exclusion Criteria
- Current participation in another caregiving evidence-based program
- Previous participation in usability testing for current system development
Data sourced from ClinicalTrials.gov (NCT04540198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.